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Address correspondence to Martha J. Morrell, 455 N. Bernardo Avenue, Mountain View, CA 94043, U.S.A. E-mail: mmorrell@neuropace.com

See publication for full list of acknowledgements.

Author Felice T. Sun certifies that she has equity ownership/stock options with NeuroPace and is an employee of NeuroPace.

Author Tracy A. Courtney certifies that she has equity ownership/stock options with NeuroPace and is an employee of NeuroPace.

Author Cairn G. Seale certifies that she has equity ownership/stock options with NeuroPace and is an employee of NeuroPace.

Author Martha J. Morrell certifies that she has equity ownership/stock options with NeuroPace and is an employee of NeuroPace.

The remaining authors have no conflicts of interest which are relevant to this research activity.

We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.

Subjects:

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Clinical Neurology
  • Neurosciences & Neurology
  • CLINICAL NEUROLOGY
  • Cortical stimulation
  • Partial seizures
  • Focal seizures
  • Responsive stimulation
  • Neurostimulator
  • QUALITY-OF-LIFE
  • DEEP-BRAIN-STIMULATION
  • RANDOMIZED CONTROLLED-TRIAL
  • VAGUS NERVE-STIMULATION
  • TEMPORAL-LOBE EPILEPSY
  • REFRACTORY EPILEPSY
  • LONG-TERM
  • STANDARDS-SUBCOMMITTEE
  • ELECTRICAL-STIMULATION
  • ANTIEPILEPTIC DRUGS

Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: Final results of the RNS System Pivotal trial

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Journal Title:

Epilepsia

Volume:

Volume 55, Number 3

Publisher:

, Pages 432-441

Type of Work:

Article | Final Publisher PDF

Abstract:

Objective To demonstrate the safety and effectiveness of responsive stimulation at the seizure focus as an adjunctive therapy to reduce the frequency of seizures in adults with medically intractable partial onset seizures arising from one or two seizure foci. Methods Randomized multicenter double-blinded controlled trial of responsive focal cortical stimulation (RNS System). Subjects with medically intractable partial onset seizures from one or two foci were implanted, and 1 month postimplant were randomized 1:1 to active or sham stimulation. After the fifth postimplant month, all subjects received responsive stimulation in an open label period (OLP) to complete 2 years of postimplant follow-up. Results All 191 subjects were randomized. The percent change in seizures at the end of the blinded period was -37.9% in the active and -17.3% in the sham stimulation group (p = 0.012, Generalized Estimating Equations). The median percent reduction in seizures in the OLP was 44% at 1 year and 53% at 2 years, which represents a progressive and significant improvement with time (p < 0.0001). The serious adverse event rate was not different between subjects receiving active and sham stimulation. Adverse events were consistent with the known risks of an implanted medical device, seizures, and of other epilepsy treatments. There were no adverse effects on neuropsychological function or mood. Significance Responsive stimulation to the seizure focus reduced the frequency of partial-onset seizures acutely, showed improving seizure reduction over time, was well tolerated, and was acceptably safe. The RNS System provides an additional treatment option for patients with medically intractable partial-onset seizures.

Copyright information:

© 2014 The Authors. Epilepsia published by Wiley Periodicals, Inc. on behalf of International League Against Epilepsy.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommerical-NoDerivs 3.0 Unported License (http://creativecommons.org/licenses/by-nc-nd/3.0/).

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